The Los Altos-based biotechnology firm confirmed that the regulator’s decision centers solely on its contract manufacturer rather than the drug's clinical performance. According to the company, the FDA has not raised objections regarding safety or efficacy data, nor has it requested additional clinical testing.

Although Unicycive signaled significant progress toward manufacturing compliance late last year, the company admitted the FDA has yet to perform a fresh inspection of the vendor. Executives remain in discussions with regulators regarding the drug's labeling and packaging. Unicycive management expressed optimism that a future facility inspection will clear the path for an expedited resubmission of their application.